Risk Based Incoming Quality Assurance (IQA)

Transcription

1 Microrite, Inc. brings you this unique learning experience in Risk Based Incoming Quality Assurance (IQA); Part of Microrite s step-by-step webinar series. Risk Based Incoming Quality Assurance (IQA) In addressing regulatory quality system needs for incoming supplied materials & components per ISO13485, GMP compliance, etc. one needs to define quality controls and documentation needs based on inspection tools or lack of. Incoming Quality (IQ) or Receiving Inspection (RI) is done more often by default or standard template then through logic approach based on needs and risks. Results are often limited to lot identity checklist and low value assessment, if any. So how effective and valuable is your incoming quality effort? Processes begin with your suppliers per your design requirements; define the means to ensure higher confidence of success By using risk management approaches and practices, such as ISO14971, one can define supplier process and incoming controls as appropriate due to risk in Critical To Quality (CTQ) materials and components. Defining a better means to implement an overall control approach including ongoing variation and change management. When? September 24 th, :00pm to 5:00pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics. Who should attend? Quality Assurance, Regulatory Affairs, Clinical Affairs, R&D, Manufacturing, and training personnel.

2 September 24 th, 2013 This 2 hour course will include: Defining an incoming quality strategy development projects, commercial projects, risk management Early development, characterization is often the key in defining critical feature(s) and risks Receiving inspection scope compliance vs. quality function trade-offs in risk mitigation Tools and gages needs and ongoing demands Calibration and resources options and requirements Qualifying and leveraging the supply base options in incoming quality approaches Defining risk, critical design features, and critical process limits Limited data, low volume realities defining a pilot build plans Defining product qualification criteria first article acceptance and ongoing lot acceptance Non-conformance response and follow up structured problem solving Qualification options & validation roles for incoming quality activities Change management considerations Data demands and management considerations Alternate and second supply sources other business realities (virtual supply chain) Disqualifying suppliers and products considerations Outsourcing portions and other options for incoming controls Regulatory minimums Using risk management for incoming quality and overall product control advantages Who will be teaching? George J. Marcel, has over 30 years experience in quality assurance applications in multiple industries (including medical device, automotive, commercial, green tech (wind power), and other high-tech industries) as a quality professional in roles as director, manager, engineer, supervisor, and project manager. George is a medical device quality consultant with over 15 years experience within the medical device industry. He has hands on experience in implementing quality management systems from start up to implementing correction in commercial systems that required revision due to non-compliance or other gaps including multiple FDA Warning letter responses. He has defined and implemented successful common sense approaches in manufacturing, design control, supplier control, document control, audits, and other QMS requirement areas. George is a senior member of ASQ for over 25 years. He has attained multiple ASQ certifications including all FDA regulated industry focused accreditation: Certified Biomedical Auditor (CBA) #625, Certified HACCP Auditor (CHA) #925, and Certified Pharmaceutical GMP Professional (CPGP) #313. He is an active member of the ASQ Biomedical Division and the Northern California Biomedical Discussion Group.

3 REGISTRATION FORM Risk Based Incoming Quality Assurance (IQA) Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) attendees $135 (per attendee)(40% Discount) Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website- or complete this form and fax to Check payments must be cleared before the webinar date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to info@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment. Webinar cancellation must be received 3 business days prior to the webinar less a 10% service fee, cancellation requests will be accepted via only. All refund requests must be made by the organizations primary contact or credit card holder. Refunds will be credited to the original credit card used to purchase the webinar.

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